How Indian E-pharmacies Operate? Rules & Regulations Governing Them
The Different Models Of E-pharmacies: 1) ‘Online Only’ Pharmacy
2) A digital twin of ‘Brick-and-Mortar’ pharmacy 3) E-pharma marketplace To start an online pharmacy, you need to understand relevant rules and regulations and follow 7 steps:
1. Drugs and Cosmetics Act, 1940 (D&C Act) DeďŹ nes the pharmacies and lays fundamental guidelines for the operation of drugs and cosmetics. It also mandates a retail license to sell the drugs on the basis of a valid prescription.
2. Drugs and Cosmetics Rules, 1945 (D&C Rule) Regulates manufacturing, sale, distribution, import and advertisements of drugs and cosmetics. Prescribes and ensures product and labelling standards.
3. Pharmacy Act, 1948 Regulates the pharmacy profession as a whole and sets rules and extent of punishment for an oence.
4. Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 Regulates advertisements of drugs relating to certain conditions and diseases.
5. Narcotic Drug and Psychotropic Substances Act, 1985 Regulates operations, including sales, relating to narcotic drugs and psychotropic substances and provides stringent punishments for matters related thereof.
6. Information Technology Act, 2000 (IT Act) Regulates the bodies or persons who deal with sensitive data of all kinds. Implements measures to ensure data privacy and penalizes disclosure of personal information without consent. It was further amended in 2011 as Information Technology (Reasonable security practices and procedures and sensitive personal data or information) Rules, 2011 to include medical records and history, biometric information, physical, physiological and mental health condition; and other such sensitive data.
7. Indian Medical Council Code of Ethics Regulations, 2002 (MCI Code) Regulates professional conduct of registered medical practitioners in India, prescribes acceptable medical practices and provides penalty for the violation of these regulations.
✔ Central Drug Standard Control Organisation (CDSCO) ✔ State Drug Standard Control Organisation ✔ The Drug Controller General of India (DCGI)
Some of the noteworthy revisions suggested in the draft rules are as follows:
1. Definition of ‘e-pharmacy’: For the first time, the term ‘e-pharmacy’ was defined; It was accurately defined as a business of distribution or sale, stock, exhibit or offer for sale of drugs through a web portal or any other electronic mode.
2. Registration of e-pharmacy: The rules require that any person intending to conduct e-pharmacy business needs to mandatorily apply for registration to the central licensing authority by ďŹ lling the form 18AA along with furnishing required documents and making a payment of INR 50,000. The validity of the registration would be three years from the date of issue. After the expiration, the pharmacist is required to renew the license.
3. Audit: The draft rules also make clear provision for a periodic inspection of the business. The e-pharmacy registration holder must allow the inspection by the authorized team of central licensing authority every two years.
4. Data Localisation: According to the draft, e-pharmacies are required to establish the e-pharmacy portal through which they conduct business in India and shall keep the data generated localised. These rules also specify that the data generated or mirrored through the e-pharmacy portal shall not be sent or stored outside India.
5. ConďŹ dentiality of the Information: The e-pharmacies are required to keep all the details of its customers discreetly. Further, they are also required to disclose these details to the concerned government for public health purposes.
6. Helpline and Grievance Redressal: The e-pharmacy registration holder will have to set up a support and grievance redressal mechanism for a minimum period of 12 hours a day for the 7 days of a week, and a registered pharmacist is required to answer the customer queries.
7. Central License: The draft rules mentioned a provision of central license from the country’s apex drug regulator, to allow them to operate across the country.
8. Regulatory Authority: These draft rules propose to appoint a central licensing authority i.e. Drug Controller General of India (DCGI) to replace state drug regulators. DCGI will be the sole authority for granting approvals with a validity of three years.
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